510(K) clearance for Merit Medical’s SwiftNinja steerable microcatheter

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Merit Medical has received 510(k) clearance for its SwiftNinja steerable microcatheter. The clearance covers peripheral and coronary applications. With the exception of Japan, Merit has global distribution rights for the SwiftNinja. The device is scheduled to be launched simultaneously with the Corvocet Biopsy System, which also received 510(k) clearance recently.

Merit’s chairman and chief executive officer, Fred P Lampropoulos, comments: “For the past several months we have been marketing this unique product with great success in Europe. Physician response relating to range, convenience and overall cost, when compared to the use of multiple devices, has validated our initial expectations. We believe these two patented and transformative technologies will provide substantial momentum and enthusiasm amongst our sales force and customers as we prepare for 2017.”